NCT04459416

Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma

Opioid-Sparing Pain Treatment In Myeloma And Lymphoma Patients Undergoing High-Dose Chemotherapy (OPTIMAL-HiChemo): Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether acupuncture treatments can reduce the need for opioid medication when managing pain caused by chemotherapy. The study will compare the effects of adding acupuncture to usual pain management with those of usual pain management alone, in reducing opioid use by relieving pain. Researchers also want to find out more about the effects of acupuncture treatments on other symptoms caused by cancer treatments and quality of life.

Conditions

• Multiple Myeloma
• Hodgkin Disease
• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
OTHER	Acupuncture	Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice.
DRUG	opioid	All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.
OTHER	Assessments	Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.

Timeline

• Start date: 2020-06-30
• Primary completion: 2024-07-02
• Completion: 2026-06-01
• First posted: 2020-07-07
• Last updated: 2025-10-20
• Results posted: 2024-12-04

Locations

3 sites across 1 country: United States